Ellner Scott J, Hoh Carl K, Vera David R, Darrah Denise D, Schulteis Gery, Wallace Anne M
Department of Surgery, University of California, San Diego, La Jolla, CA 92093, USA.
Nucl Med Biol. 2003 Nov;30(8):805-10. doi: 10.1016/j.nucmedbio.2003.10.001.
[(99m)Tc]DTPA-mannosyl-dextran is a receptor-binding radiopharmaceutical specifically designed for sentinel lymph node mapping. The purpose of this study was to test the biodistribution and safety of [(99m)Tc]DTPA-mannosyl-Dextran at different molar doses. Twenty-four female breast cancer patients participated in this study. Four groups of 6 patients received an injection of 0.2, 1.0, or 5.0 nmol of [(99m)Tc]DTPA-mannosyl-Dextran or filtered [(99m)Tc]sulfur colloid. The injection site clearance was monitored by dynamic imaging for three hours. Whole body scans were acquired at 2.5 and 12, and lymph nodes were assayed for radioactivity after gamma-guided sentinel lymph node biopsy. Injection site clearance of [(99m)Tc]DTPA-mannosyl-Dextran was not statistically different in a dose-dependent manner. Dose-dependent sentinel node uptake was observed (p = 0.03). There were no clinically significant alterations in laboratory parameters among all dose levels at 4 h or 24 h post injection compared to preoperative levels. Radiation absorbed doses did not differ among the three dose levels, but were lower than filtered [(99m)Tc]sulfur colloid.
[（99m）Tc]二乙三胺五乙酸-甘露糖基葡聚糖是一种专门设计用于前哨淋巴结定位的受体结合放射性药物。本研究的目的是测试不同摩尔剂量的[（99m）Tc]二乙三胺五乙酸-甘露糖基葡聚糖的生物分布和安全性。24名女性乳腺癌患者参与了本研究。四组，每组6名患者，分别接受注射0.2、1.0或5.0纳摩尔的[（99m）Tc]二乙三胺五乙酸-甘露糖基葡聚糖或经过滤的[（99m）Tc]硫胶体。通过动态成像监测注射部位清除情况，持续三小时。在2.5小时和12小时进行全身扫描，并在γ引导下进行前哨淋巴结活检后测定淋巴结的放射性。[（99m）Tc]二乙三胺五乙酸-甘露糖基葡聚糖的注射部位清除情况在剂量依赖性方面无统计学差异。观察到前哨淋巴结摄取呈剂量依赖性（p = 0.03）。与术前水平相比，在注射后4小时或24小时，所有剂量水平的实验室参数均无临床显著改变。三个剂量水平的辐射吸收剂量无差异，但低于经过滤的[（99m）Tc]硫胶体。
